Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | MEDTRONIC INSYNC MARQUIS MODEL 7277 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION 3 |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S003 |
Date Received | 11/13/2002 |
Decision Date | 03/27/2003 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MEDTRONIC INSYNC MARQUIS MODEL 7277 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH CARDIAC RESYNCHRONIZATION THERAPY AND INSYNC MARQUIS APPLICATION SOFTWARE MODEL 9983 AND FOR THE SYSTEM TO BE MANUFACTURED AT MED REL, HUMACACO, PUERTO, RICO, MEDTRONIC, EUROPE S.A, TOLOCHENAZ, SWITZERLAND AND MEDTRONIC BV, KERKRADE, THE NETHERLANDS. |
|
|